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Glossary · Tier 1

FDA Approval

Also known as: FDA-approved, FDA drug approval, CDER approval

Verified from FDA on 06-02-2026
Quick answer

FDA approval refers to the regulatory clearance issued by the U.S. Food and Drug Administration before a prescription or over-the-counter drug can be marketed in the United States. Within the FDA, the Center for Drug Evaluation and Research (CDER) oversees the review process that determines whether a drug's benefits outweigh its known risks for its intended use. The FDA describes the broader framework and CDER's consumer protection role in the passage below.

MedivaScan summary. The authoritative source quote follows below.

FDA definition

American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA's Center for Drug Evaluation and Research (CDER).

U.S. Food and Drug AdministrationView on source ›Verbatim quote. Last verified 06-02-2026.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.